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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00458887




Registration number
NCT00458887
Ethics application status
Date submitted
9/04/2007
Date registered
11/04/2007
Date last updated
13/03/2017

Titles & IDs
Public title
Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin
Scientific title
A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy
Secondary ID [1] 0 0
COG-ACCL05C1
Secondary ID [2] 0 0
ACCL05C1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ototoxicity 0 0
Unspecified Childhood Solid Tumor, Protocol Specific 0 0
Condition category
Condition code
Ear 0 0 0 0
Other ear disorders
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - management of therapy complications

Ancillary/Correlative (ototoxicity assessment) - Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic emission testing) for management of therapy complications before the first course of planned cisplatin, before each subsequent course of cisplatin, and 4 weeks after the last dose of cisplatin.

Patients who are scheduled to receive hematopoietic progenitor stem cell transplantation undergo hearing tests for management of therapy complications before the transplantation and 4 weeks after transplantation.


Treatment: Surgery: management of therapy complications
Undergo hearing tests
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria
Timepoint [1] 0 0
Length of study
Primary outcome [2] 0 0
Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing
Timepoint [2] 0 0
Length of study
Primary outcome [3] 0 0
Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations)
Timepoint [3] 0 0
Length of Study

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Planning to undergo treatment with any cisplatin-containing therapeutic regimen for cancer

* Treatment does not need to be on a COG therapeutic study
* Planning to enroll on clinical trial ACCL0431

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior cisplatin
Minimum age
1 Year
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2017
Sample size
Target
Accrual to date
Final
301
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Connecticut
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Delaware
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United States of America
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Florida
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maryland
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Michigan
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Minnesota
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Missouri
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Dakota
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Tennessee
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Texas
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Virginia
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Washington
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United States of America
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Wisconsin
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Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
Manitoba
Country [36] 0 0
Canada
State/province [36] 0 0
Nova Scotia
Country [37] 0 0
Canada
State/province [37] 0 0
Ontario
Country [38] 0 0
Canada
State/province [38] 0 0
Quebec
Country [39] 0 0
Canada
State/province [39] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: New ways to find out about hearing loss after treatment with chemotherapy may improve the ability to plan cancer treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is assessing ear damage in young cancer patients treated with cisplatin.
Trial website
https://clinicaltrials.gov/study/NCT00458887
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lillian Sung, MD, PhD
Address 0 0
The Hospital for Sick Children
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00458887